Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth (DOORWAY)
2014年7月18日 更新者：Professor Francine Ducharme、St. Justine's Hospital
The aim of the prospective cohort study is to: (1) document the magnitude of response to oral corticosteroids administered to children presenting to the emergency department with moderate or severe asthma and (2) quantify clinically available potential determinants of the response to corticosteroids, such as age, gender, triggers of the index exacerbation, environmental tobacco smoke (ETS), gene polymorphisms, and their interactions.
調査の概要
状態
完了
条件
詳細な説明
The objective of the large multicentre cohort study is to quantify the response to oral corticosteroids in children aged 1 to 17 years presenting to the ED with a moderate or severe asthma exacerbation.
The main outcome is hospital admission within 72 hours of the oral corticosteroid administration.
Secondary outcomes include the change in Pediatric Respiratory Assessment Measure (PRAM), length of active treatment and other markers of response to therapy in the ED as well as markers of recovery over the next 10 days.
研究の種類
観察的
入学 (実際)
1011
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Quebec、カナダ、G1V 4G2
- Centre Hospitaliser de l'Université Laval
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Ontario
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London、Ontario、カナダ、N6A 2V5
- Children's Hospital of London Health Sciences Centre
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Ottawa、Ontario、カナダ、K1H 8L1
- Children's Hospital of Eastern Ontario
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Quebec
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Montreal、Quebec、カナダ、H3T1C5
- CHU Sainte-Justine (CHUSJ)
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Montreal、Quebec、カナダ、H3H 1P3
- Montreal Children's Hospital (MCH)
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
1年～17年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
Children aged 1 to 17 years with moderate to severe asthma with Pediatric Respiratory Assessment Measure (PRAM) ≥4.
説明
Inclusion Criteria:
Subject will be eligible if he/she:
- is aged 1 to 17 years,
- has not received any oral, IM or IV corticosteroid within the last 5 days?
- Presents to the hospital emergency department with an acute episode of cough, wheezing and/or dyspnea?
Has asthma as defined as one or more of the following 6 criteria:
(i) prior diagnosis of asthma made by a physician; OR (ii) prior documented episode of acute cough, wheezing and/or dyspnea with significant response to inhaled β2-agonists or to oral corticosteroids; OR (iii) in a child aged <2 years, 3 or more episodes of cough, wheezing and/or dyspnea, including the index visit; OR (iv) previous lung function tests showing significant reversibility post-bronchodilation (≥12% FEV1 or ≥25% Rrs at 4 to 8 Hz); OR (v) a positive provocation test (PC20 ≤8 mg/mL or Provocation Dose (to increase Rrs by 50% or more (PD50) ≤8 mg/mL), OR (vi) the current episode diagnosed or suspected of asthma by the emergency physician?
- have moderate or severe airway obstruction, defined as a Paediatric Respiratory Asthma Measure (PRAM) score >3 at baseline,
Exclusion Criteria:
Patient will be excluded if :
- he/she has another chronic respiratory condition (such as bronchopulmonary dysplasia or cystic fibrosis);
- there is a reasonable suspicion of bronchiolitis or foreign body aspiration;
- he/she has a prior history of hypersensitivity to salbutamol, ipratropium bromide or oral prednisone/prednisolone;
- he/she has a relative or absolute contraindication to receiving oral corticosteroids such as recent exposure to varicella or live vaccine in past 14 days,
- there is confirmed or suspected pregnancy.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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Oral corticosteroids (OCS)
All patients receive:
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Hospital admission
時間枠：72 hours after oral corticosteroids administration
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Hospital admission or Length of active treatment for 8 or more hours after the oral corticosteroid administration or ED return visit associated with hospital admission within 72 hours after the oral corticosteroid administration or ED return visit associated within 72 hours with length of active treatment for 8 or more hours after the oral corticosteroid administration
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72 hours after oral corticosteroids administration
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Length of active treatment in hospital
時間枠：8 hours after oral corticosteroid administration
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8 hours after oral corticosteroid administration
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Meeting the severity criteria for admission
時間枠：Within 4 hours of oral corticosteroid administration
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Proportion of children with a PRAM score ≥4 within 4 hours of oral corticosteroid administration
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Within 4 hours of oral corticosteroid administration
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PRAM profile in the ED
時間枠：Within 4 hours of oral corticosteroid administration
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Area under the curve of the PRAM measured hourly for the time of oral corticosteroid (OCS) until 4 hours after OCS
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Within 4 hours of oral corticosteroid administration
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Time to meeting discharge criteria
時間枠：Within 8 hours of oral corticosteroid administration
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Time until PRAM score ≤ 3
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Within 8 hours of oral corticosteroid administration
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Change in respiratory resistance
時間枠：Within 4 hours of oral corticosteroid administration
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Change in respiratory resistance between baseline and disposition will be documented on the MasterScreen Impulse Oscillometry (Cardinal Health Canada, Montreal, Canada) using previously described standardized techniques in cooperative children aged ≥3 years.
(measured in a subset of individuals)
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Within 4 hours of oral corticosteroid administration
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Unscheduled visits for asthma
時間枠：Within 7 days of the index ED exacerbation
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unscheduled visits for asthma as reported by parents and confirmed by medical charts.
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Within 7 days of the index ED exacerbation
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Symptom score
時間枠：Within 7 days of the index ED exacerbation
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Area under the curve of symptoms measured daily on the validated Asthma flare-up diary for children
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Within 7 days of the index ED exacerbation
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Duration of asthma symptoms
時間枠：Within 7 days of the index ED exacerbation
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Duration of symptoms measured daily on the validated Asthma flare-up diary for children
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Within 7 days of the index ED exacerbation
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Cumulative reliever use
時間枠：Within 7 days of the index ED exacerbation
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Cumulative number of puffs of reliever medication as recorded daily on the Asthma flare-up diary for children
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Within 7 days of the index ED exacerbation
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Duration of use of rescue ß2-agonists
時間枠：Within 7 days of the index ED exacerbation
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Duration of use of rescue ß2-agonists as recorded on the Asthma flare-up diary for children
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Within 7 days of the index ED exacerbation
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Adverse events
時間枠：Within 7 days of the index ED exacerbation
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Number of children with vomiting, serious Infection, psychosis, and mood disturbances
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Within 7 days of the index ED exacerbation
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Serious Adverse Health Events
時間枠：Within 7 days of the index ED exacerbation
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Number of children with adverse events requiring hospitalization, prolonged hospitalization, life threatening, other medically important events or associated with significant disability or incapacity
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Within 7 days of the index ED exacerbation
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Francine M Ducharme, MD., M.Sc.、CHU Sainte Justine, University of Montreal
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Tse SM, Krajinovic M, Chauhan BF, Zemek R, Gravel J, Chalut D, Poonai N, Quach C, Laberge S, Ducharme FM; DOORWAY research group of the Pediatric Emergency Research in Canada (PERC) network. Genetic determinants of acute asthma therapy response in children with moderate-to-severe asthma exacerbations. Pediatr Pulmonol. 2019 Apr;54(4):378-385. doi: 10.1002/ppul.24247. Epub 2019 Jan 15.
- Merckx J, Ducharme FM, Martineau C, Zemek R, Gravel J, Chalut D, Poonai N, Quach C; Pediatric Emergency Research Canada (PERC) DOORWAY team. Respiratory Viruses and Treatment Failure in Children With Asthma Exacerbation. Pediatrics. 2018 Jul;142(1):e20174105. doi: 10.1542/peds.2017-4105. Epub 2018 Jun 4.
- Ducharme FM, Zemek R, Chauhan BF, Gravel J, Chalut D, Poonai N, Guertin MC, Quach C, Blondeau L, Laberge S; DOORWAY research group of the Pediatric Emergency Research in Canada (PERC) network. Factors associated with failure of emergency department management in children with acute moderate or severe asthma: a prospective, multicentre, cohort study. Lancet Respir Med. 2016 Dec;4(12):990-998. doi: 10.1016/S2213-2600(16)30160-6. Epub 2016 Jul 20.
- Ducharme FM, Zemek R, Gravel J, Chalut D, Poonai N, Laberge S, Quach C, Krajinovic M, Guimont C, Lemiere C, Guertin MC. Determinants Of Oral corticosteroid Responsiveness in Wheezing Asthmatic Youth (DOORWAY): protocol for a prospective multicentre cohort study of children with acute moderate-to-severe asthma exacerbations. BMJ Open. 2014 Apr 7;4(4):e004699. doi: 10.1136/bmjopen-2013-004699.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年1月1日
一次修了 (実際)
2014年1月1日
研究の完了 (実際)
2014年1月1日
試験登録日
最初に提出
2013年12月11日
QC基準を満たした最初の提出物
2013年12月11日
最初の投稿 (見積もり)
2013年12月17日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年7月22日
QC基準を満たした最後の更新が送信されました
2014年7月18日
最終確認日
2014年7月1日
詳しくは
本研究に関する用語
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。